Maps to
FDA QMSR (Part 820): §820.184
ISO 13485: ISO 13485 §4.2.3 / 4.2.5
Requirement text
Records shall be maintained to provide evidence of conformity and effective QMS operation.
Atomic constraints
- •Records must be legible and retrievable
- •Retention periods must be defined
- •Storage conditions must be specified
- •Protection from damage and deterioration required
Evidence signals
- •
FILE_EXISTS
(Record.*Retention|Record.*Storage|Archiv|Record.*Procedure)
- •
CONTENT_MATCH
Does this document describe record storage, retention periods, or record protection procedures?
Audit defense
Record control for our QMS is defined in [your document ID]. All QMS records are legible, protected from deterioration, and retrievable within defined timeframes. Retention periods are established for each record type per ISO 13485 4.2.5.